A great deal of descriptive material concerning multiplex assay technologies has been written and discussed during the past decade. Multiplex Assays: Evolving Technologies, Applications and Future Directions focuses mainly on significant recent developments in the multiplex assay field.

Pharmaceutical companies are also increasingly committing to associating their drugs with diagnostic assays. The majority of these are single-analyte biomarkers. However a number of multiplex biomarkers not directly associated with particular drugs are in use as approved or homebrew diagnostics, and these contribute in various ways to the broad field of translational medicine. This report examines the role of multiplex and multi-analyte biomarker assays in translational medicine. We deal with their direct contributions to drug discovery and development; their contributions as theranostics, companion diagnostics, etc.; and the reasons why they are not more prevalent despite their apparent high potential.

Following a brief introduction, Chapter 2 provides background, definitions, describes the evolution of multiplex assays, and the development of translational medicine as both a concept and a manifest reality.

Chapter 3 provides an in depth examination of technological aspects of multiplex assays with emphasis on transcriptomics, proteomics, and metabonomics. The emphasis here is on recent developments and newer players in the multiplex assay field. Also included is a discussion of the potential role of next-generation sequencing in replacing DNA microarray technology for transcriptomics.

Chapter 4 examines applications of multiplex assays in translational medicine, and does so from the perspective of pharma R&D, companion diagnostic products, and the new diagnostics as a contributor to translational medicine.

Chapter 5 places the emphasis on market perspectives in the field. We examine the competitive environment in “omics” technology via results of an online survey of people active in the field, and also examine recent deal activity and what it reveals about the market for multiplex assays and their technologies.

Chapter 6 of the report makes some general observations relevant to a number of issues raised in earlier chapters, leaning heavily on extracts from interviews conducted for this report with people highly knowledgeable in this field. Extracts from these interviews are also to be found in earlier chapters where relevant to highlight various issues. Complete transcripts of these interviews are contained in Chapter 7.

About the author:Ken Rubenstein, PhD, a biochemist and molecular biologist, received his PhD at the University of Wisconsin and postdoctoral training at the University of Pennsylvania School of Medicine. He was a key innovator and research manager for Syva Company, the diagnostics branch of Syntex Corporation. During his 13 years with Syva, Dr. Rubenstein became vice president, scientific affairs, a function that included strategic planning. Since 1983, he has served as a technology and marketing consultant to biomedical companies and an industry analyst, with more than 40 published studies to his credit.